Knee osteoarthritis Musculoskeletal Diseases
Conditions
Interventions
Participants will be selected based on inclusion criteria. After which they will be randomly allocated into one of two treatment groups. One group will consist of a minimum of forty (N=40) participant
Sponsors
St Catherine Specialty Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with osteoarthritis of the knee who are aged 30-75 years old 2. Osteoarthritis grade 2-3 based on Kellgren-Lawrence classification 3. Patellofemoral osteoarthritis Iwano grade 2-3 4. Presence of knee pain for at least six months 5. Patients who have lower limb axis deviation less than 5° 6. The possibility of following research instructions and responding to control examinations 7. Signed informed consent for participation in the research
Exclusion criteria
Exclusion criteria: 1. Malignant diseases, systemic inflammatory diseases (e.g. rheumatoid arthritis, psoriatic arthritis) or other systemic diseases that can result in knee pain or cause systemic inflammation 2. A body mass index (BMI) greater than 30 or diabetes 3. Six or more painful points on the body, distributed above and below the waist, on both sides of the body and in the axilla 4. Depression (determined according to the CESD-R questionnaire) 5. Stage 4 of the Kellgren-Lawrence classification for knee osteoarthritis, stage 4 of the Iwano classification of patellofemoral arthrosis 6. A MOAKS score for synovitis or effusion less than 2 (patients without knee effusion) 7. Post-traumatic osteoarthritis 8. A history of surgery on the affected knee 9. A deviation of the mechanical axis (valgus/varus) of the lower extremities greater than 5° 10. An unstable knee 11. Damage to the meniscus or other knee structures as the main cause of pain and other symptoms (radial rupture and bucket-handle rupture of the meniscus, ACL rupture, subchondral cysts according to MRI) 12. An injury of the affected knee in the last 3 months 13. Received an intra-articular injection in the affected knee (corticosteroids, hyaluronic acid, platelet-rich plasma, etc.) within the last 3 months 14. Other musculoskeletal problems/diseases (genetic diseases such as Marfan syndrome or osteogenesis imperfecta) that would prevent clinical evaluation of the effects of MFAT or HA treatment 15. Unable to abstain from oral non-steroidal anti-inflammatory drugs (NSAIDs) for 7 days prior to MFAT or HA application and during the 6-month follow-up 16. Allergy to lidocaine and adrenaline 17. A blood coagulation disorder, thrombocytopenia or patients on anticoagulant therapy with a prothrombin time <0.70 18. Systemic immunosuppressive therapy 19. Chondromatosis or villonodular synovitis of the knee joint 20. Knee joint infection 21. Pregnancy or planning to become pregnant during the study period 22. History of chemotherapy or radiotherapy of the extremities or in the area of fat tissue extraction 23. Mental illnesses (who cannot be expected to cooperate during the project) 24. Unable to respond to follow-up examinations
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Knee symptoms, pain and function measured by patient-reported outcomes measures (PROMs) using a visual analog scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Knee Injury and Osteoarthritis Outcome Score (KOOS), International Knee Documentation Committee (IKDC), Oxford Knee Score and Tegner/Lysholm knee score at baseline, 1-month and 6-month follow up | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Articular cartilage glycosaminoglycan content is measured indirectly using Delayed Gadolinium-Enhanced Magnetic Resonance Imaging of Cartilage (dGEMRIC) at baseline and 6-month follow-up 2. Osteoarthritic changes of the knee assessed using the Magnetic Resonance Imaging Osteoarthritis Knee Score (MOAKS) at baseline, 1-month and 6-month follow-up 3. Concentration of cytokines and chemokines in synovial fluid measured using a personalized panel for multiplex enzyme-linked immunosorbent assay (ELISA) at baseline and 1-month follow-up. The panel will include: IL-1ß, IL-1Ra, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, IL-12, IL-13, IL-15, IL-17A, IL-18, IL-21, IL-22, TNF-a, IFN-?, TGF-ß1, TGF-ß2, MMP-1, MMP-2, MMP-3, MMP-8, MMP-9, MMP-13, TIMP1, TIMP2, TIMP3, TIMP4, sICAM-1, V-CAM1, VEGF, ADAMTS-4, ADAMTS-5, COMP, CTX-I, CTX-II, Leptin, CCL2 (MCP1), CCL3 (MIP-1a), CCL4 (MIP-1b), CCL5 (RANTES), CCL7 (MCP-3), CXCL-12 (SDF-1). 4. Concentration of cytokines and chemokines in plasma measured using the personalized panel for multiplex ELISA at baseline, 1-month and 6-month follow-up 5. miRNA expression profile in synovial fluid analyzed using next-generation sequencing at baseline and 1-month follow-up 6. miRNA expression profile in plasma analyzed using next-generation sequencing at baseline, 1-month and 6-month follow up 7. N-glycans in synovial fluid measured using ultra-performance liquid chromatography (UPLC) system with fluorescence (FLR) detection at baseline and 1-month follow-up 8. N-glycans in plasma measured using ultra-performance liquid chromatography (UPLC) system with fluorescence (FLR) detection at baseline, 1-month and 6-month follow up 9. Phenylalanine concentration measured using tandem mass spectrometry in the plasma at baseline, 1-month and 6-month 10. Concentration of cytokines and chemokines in microfragmented adipose tissue (MFAT) is measured using the personalized panel for multiplex ELISA at baseline 11. miRNA expression profile in MFAT analyzed using ne | — |
Countries
Croatia, Slovenia
Outcome results
None listed